BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 960444 · Received December 5, 2007

    Report

    Report Number
    1628664-2007-00572
    Event Type
    Other
    Date Received
    December 5, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 9, 2007
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED DISCREPANT PATIENT RESULTS HAVE BEEN GENERATED ON THE ARCHITECT C8000 POTASSIUM ASSAY. A PLASMA SPECIMEN FROM A PATIENT GENERATED A POTASSIUM RESULT OF 5.99 MMOL/L, BUT A CORRESPONDING SERUM SPECIMEN HAD A VALUE OF 4.26 MMOL/L. NO IMPACT TO PATIENT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 CLINICAL CHEMISTRY ANALYZER JJE ABBOTT MFG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR AEROSET/C8000 ICT MODULE LIST# 9D28-03